This invention relates to an improved method of controlling and treating diseases of the teeth and periodontium by applying an oral lavage thereto.
Periodontal disease is one of the world's most prevalent diseases and is the primary cause of tooth loss in adults throughout the world.
After teeth are cleaned, they soon become coated with "plaque" which is comprised of organic deposits from saliva, desquamated epithelial cells and masses of oral microorganisms which not only cause caries in the teeth, but are also believed to be the cause of chronic disease of the periodontal tissues. The primary techniques presently employed for removing plaque and the bacteria contained therein surrounding the teeth is (a) mechanical means of scaling or root planing the teeth by a dentist or oral hygienist or (b) flossing the teeth by the patient.
The specific identity of the bacteria in the mouth which causes periodontal diseases may vary. Bacteria which have been implicated as causing periodontal disease include Actinomyces viscosus, Bacteroides intermedius, and Bacteroides gingivalis. Although certain chemicals such as alcohol, iodine and the like have been used in the preparation of oral lavages or antiseptics to control the periodontal bacteria, none of these oral lavages have been found to be suffiently effective in controlling the periodontal bacteria and hence the disease.
Recent research has shown that periodontal disease can be controlled and treated by the use of certain topically applied antimicrobial agents. Chlorhexidine has, for example, been proven effective in treating periodontal disease. However, the Federal Drug Administration has not permitted these topical agents to be marketed in the United States because of toxicity or cosmetic problems, even though the agents have been proven to be effective in the treatment of periodontal disease. There is a need for an oral lavage which will treat and control periodontal disease and which is cosmetically acceptable and free of toxicity problems.
Recently, Dr. Paul H. Keyes and Associates proposed a method for controlling periodontal disease by daily brushing of the teeth and gums with a dentifrice comprised of a thick mixture of baking soda moistened with a 3 percent solution of hydrogen peroxide. Following brushing of the teeth and massaging of the gums with this paste, the mouth is rinsed with salt water. Although this technique has received extensive publicity and has been used as a remedy by many individuals, its claimed benefits have not been substantiated or reproduced by controlled experimentation. In addition, the high sodium concentration of ingredients used in this technique may be undesirable for use by individuals suffering from hypertension.
There is a need at the present time for an oral lavage which will control the growth of microorganism which cause periodontal disease, thereby reducing the loss of teeth.
It is a primary object of this invention to provide such an improved oral lavage for use in controlling periodontal disease in the mouth.
It is a further object of this invention to provide an improved oral lavage which is substantially free of sodium for use in controlling the growth of bacteria which cause periodontal disease in the mouth.
Still another object of the invention is to provide an improved method of controlling and treating periodontal disease with an oral lavage.
These and other objects of the invention will be apparent from the following detailed description thereof.
It has now been discovered that the foregoing objects of this invention are accomplished in a method of controlling disease of the teeth and periodontium which comprises applying to said teeth and periodontium an oral lavage comprised of an aqueous solution of hydrogen peroxide and povidone iodine complex wherein said oral lavage contains from about 0.5 to about 10 percent by weight of hydrogen peroxide and from about 0.05 to about 2.0 percent by weight of iodine derived from said complex.
More in detail, the oral lavage used in the method of this invention is prepared by admixing an aqueous solution of hydrogen peroxide with a povidone-iodine complex. Hydrogen peroxide is available commercially as an aqueous solution in a wide variety of concentrations ranging from about 3 to about 30 percent.
Povidone iodine complex is also available in a wide variety of concentrations ranging from about 0.5 to about 10.0 percent. If desired, sufficient solid povidone iodine complex may be added directly to the aqueous hydrogen peroxide solution to obtain the desired iodine concentration. In addition, solid povidone iodine complex may be used to first form an aqueous solution or an aqueous alcoholic solution of the complex before admixing with the hydrogen peroxide solution to the desired concentration level. The povidone iodine complex is a complex of iodine with 1-vinyl-2-pyrrolidinone polymers, as described in U.S. Pat. Nos. 2,706,702; 2,876,532; and 2,900,305. The term "iodine by weight derived from the povidone iodine complex" as used throughout the description and claims is that amount of iodine present in the form of titratable diatomic iodine using sodium thiosulfate. This is also identified as "I.sub.2 ", particularly in the examples, while the povidone iodine complex is identified as "PVP-I.sub.2 ".
Both the hydrogen peroxide and povidone iodine complex are soluble in water which serves as a carrier and medium for their interaction when admixed in accordance with this invention. The hydrogen peroxide and povidone iodine complex are admixed in sufficient proportion to provide a mixture which serves as an oral lavage having a concentration of hygrogen peroxide in the range of from about 0.5 to about 10 percent, and preferably from about 1.0 and about 4.0 percent, by weight of the mixture.
Sufficient povidone iodine complex in one of the aforesaid forms is admixed to provide a mixture useful as an oral lavage which contains from about 0.05 to about 2.0 percent, and preferably from about 0.12 and about 0.5 percent iodine by weight derived from the povidone iodine complex. The povidone iodine complex when in solution form may also contain flavoring agents as well as buffering agents to maintain the proper pH to enhance the stability of the complex over an acceptable period of time while stored and not in use.
The oral lavage of this invention should be used as soon as possible after the hydrogen peroxide solution is admixed with the povidone iodine complex in the above-defined proportions. The resulting oral lavage may be applied to teeth, gums and other teeth supporting structures by rinsing the mouth in the same manner as with a conventional mouthwash. While the intensity of the periodontal disease may vary with the individual, effective treatment has been observed when the oral lavage is retained in the mouth for about 20 to about 40 seconds. Rinsing the mouth in this manner is preferably effected from about three to about seven times per week. However, the frequency of the application may be varied for each individual.
Highly improved results are achieved if the solution is also infused by the dentist to the periodontium and teeth by an ordinary irrigating device known to be conventional in the dental art. Applying the oral lavage between the gums and teeth, preferably below the gum line, by an irrigating device has been found to be an effective means of controlling periodontal disease.
It has been found that when the weight ratio of hydrogen peroxide to iodine derived from the povidone iodine complex in the oral lavage is in the range from about 0.25:1 to about 200:1 and preferably from about 2:1 to about 40:1, the oral lavage is very effective in controlling diseases which have been implicated as causing periodontal disease. Without being bound by theory, it is believed that when the oral lavage containing hydrogen peroxide is present in the mouth, there is a greater amount of iodine released from the complex. This action insures a greater degree of germicidal activity by the iodine itself, as well as by the accompanying oxygen liberated from the hydrogen peroxide component of the oral lavage. This not only increases the germicidal potential of the iodine itself, but also insures that a broad spectrum of periodontal bacteria may be destroyed by the oral lavage of this invention in a more effective and efficient manner when compared to the oral lavages of the prior art.
In practice, the oral lavage of this invention functions to improve anticepsis on the surface of the teeth and gums. This action insures that more effective protection is maintained in the interim between normal periodic visits for professional dental care. In many cases, as a result of such everyday self-care by the individual himself, the professional care required during such visits is minimized.
In carrying out the method of this invention, the above described ingredients for preparing the oral lavage in the above described proportions are provided in separate packages, each package containing one of the described ingredients in the measured amounts desired. Just prior to use, each of the packages is opened, the contents are admixed in a single vessel and applied to the teeth and gums. In the present state of the packaging technology, it is possible to package each liquid ingredient in the desired amounts in a single segmented container or package. Each of the separate compartments may be manually broken, and the measured ingredients may be admixed within the package and supplied to the teeth and gums as an oral lavage. Alternatively, the container or package can be separated by a frangible barrier therebetween to form the containers, one for each of the components of the oral lavage. When use is desired, the barrier may be easily broken and both ingredients are admixed within the container and then applied to the mouth as an oral lavage.
The oral lavage of this invention when prepared and used as described, provides an unexpectedly improved cleansing effect upon the gums and surfaces of teeth, thereby reducing the broad spectrum of aerobic and anaerobic microorganisms on such surfaces.
Some people, more than others, have a greater propensity for bacterial-caused diseases of the mouth, teeth and periodontium. The use of the oral lavage herein described by these people in particular is very advantageous. The protection achieved by periodic visits for ordinary professional care by these people is substantially enhanced in the interim periods by frequent use of the oral lavage of this invention.
In some cases, the necessity for the application of restoratory and reconstructive procedures is substantially reduced with regular application of the oral lavage of this invention. Evidence of other oral diseases is also substantially decreased due to the interfunctional activity of each of the components of the oral lavage of this invention.